Project manager / Intelligence engineering Responsible to lead and coordinate the execution of critical to business programs from concept development through manufacturing transfer and commercialization. The Responsibilities will include the management of disposable programs leading to the transformation of organ transplant in the US and worldwide. This is a high visibility role, requiring decisive judgment and interaction with multiple internal and external teams. The ideal candidate is a technically capable, results-oriented leader with experience in developing and implementing program management tools to successfully execute programs. Manage project tasks, Gantt charts and resources, communicate with stakeholders, and address any issues that arise, often working with multiple engineering, Quality and Operations disciplines. Work in close cooperation with the engineering members and RA/QA to coordinate the tasks leading to the submission strategy and with Operations to ensure the introduction and the scalability of the new products in the Manufacturing line.
Key Responsibilities Define the Project plan and build Gantt charts working in close cooperations with all the functions impacting the Program Involve internal and external technical resources to support the programs Work collaboratively with product development, manufacturing engineering, and quality teams to execute programs on time and on budget Build and implement program management tools and processes to effectively execute programs Timely tracking and presentation of program status Perform other TransMedics tasks and duties as required
Requirements Leadership role responsible for managing programs 10+ years experience in FDA/ISO regulated complex medical device development with emphasis on perfusion systems 5+ years of experience in similar role as Engineering Intellingence / Project Manager Detail oriented with strong organizational skills Strong leadership and interpersonal skills Strong program management skills with accountability for budgets, Gannt charts, milestones, and deliverables Excellent verbal and written communication skills in English; Italian language skills are preferred Effective analytical and decision making skills Must have a proven history of working in a fast-paced environment with a demonstrated ability to adjust to changing priorities Broad experience in design of medical devices and manufacturing processes of disposables, polymeric, biomedical device environment, measurement systems Master's degree or PhD in Biomedical Engineering, Mechanical Engineering, or related field Ability to bring disruptive medical technologies from concept to commercialization Experience with Class III devices, extracorporeal (ECMO) technology and life-critical medical devices strongly preferred Experience managing projects in multi-disciplinary technical teams Proven track record leading Programs to successful product launches and commercialization Ability to work in an international environment Highly motivated to enhance products, techniques and consequently the life of the patients Willingness to relocate to Mirandola, Italy